ISO 17025 Accredited, ISO 9001 Certified, and FDA 21 CFR Part 11-compliant

What is the difference between temperature mapping and validation?

Estimated reading time: 2 minutes

In the context of temperature compliance, “validation” and “temperature mapping” are two separate – but highly linked – concepts. Let’s explore the differences between them.

In the article, we’ll go through:

  • The very short version
  • What is validation, and why is it important?
  • What is temperature mapping, and why is it important?

The very short version

  • Validation focuses on evaluating the overall performance and compliance of a temperature-controlled system, ensuring it meets specified requirements. 
  • Temperature mapping specifically examines the temperature distribution within a defined space (fridge, freezer, warehouse, etc.), providing insights into areas that may or may not be fit for storing temperature-sensitive products, placing temperature monitoring data loggers, or in other ways require attention to achieve optimal temperature control and compliance.

What is validation?

In the context of temperature compliance, validation refers to the process of verifying that a temperature-controlled system, process, or method is suitable for the intended purpose, delivers the expected results, and meets specific requirements or standards. It involves assessing whether the system is capable of maintaining temperatures within predetermined limits. 

It involves assessing factors such as: 

  • temperature uniformity
  • stability
  • control accuracy
  • response time

Validation is the overall process towards compliance – it contains installation, qualification, or commissioning of the equipment or systems and can be repeated periodically to ensure ongoing compliance.

Why is validation important?

Validation aims to ensure that the temperature-controlled system is reliable, accurate, and suitable for its intended purpose.


9 temperature mapping mistakes to avoid

What is temperature mapping?

The validation process typically includes various tests, measurements, and documentation to demonstrate that the system consistently operates within the desired temperature range – one of these is mapping studies.

Mapping, also known as temperature mapping or thermal mapping, involves the detailed measurement and analysis of temperature distribution within a defined space or area such as storage areas, warehouses, cold rooms, fridges, freezers, or transport vehicles. 

The objective of mapping is to understand the temperature variations and identify potential hotspots or cold spots within the area under consideration. This is typically done using temperature data loggers or sensors placed strategically throughout the space.

Why is temperature mapping important?

Mapping is essential to evaluate the effectiveness of a temperature-controlled environment. It helps identify temperature gradients, zones of potential non-compliance, and areas that may require adjustments or modifications to ensure uniform temperature distribution.

Also watch: The 14 elements of a top-notch mapping protocol for GMP and GDP

Read more articles

Get the

FDA 21 CFR Part 11


Register for the webinar